- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02507635
Anti-inflammatory H1 Antihistamines Allergic Rhinitis
In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.
We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.
Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.
The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.
Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).
A TSS<6 means a mild rhinitis, while a TSS> 6 represented a moderate severe one.
The patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma.
The biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha.
Clinical and biological evaluation were performed before and after treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- persistent allergic rhinitis
Exclusion Criteria:
- the presence of asthma or nasal polyps,
- acute and chronic upper respiratory infections,
- administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: healthy volunteers
|
|
Active Comparator: Desloratadine
patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks
|
administration of Desloratadine 5 mg/day for 4 weeks
Other Names:
|
Active Comparator: Levocetirizine
patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks
|
administration of Levocetirizine 5 mg/day for 4 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
efficacy of H1 antihistamines (patients evaluation)
Time Frame: 4 weeks
|
patients evaluation before and after 4-weeks treatment
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)
Time Frame: 1.5 years
|
incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion
|
1.5 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Antagonists
- Cholinergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Levocetirizine
- Desloratadine
Other Study ID Numbers
- 535
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